(90 days)
SCS 17-01 is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the sketal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.
SCS 17-01 is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PQ4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CoH30], hyaluronic acid (HA), and water for injection. SCS 17-01 is provided sterile for single use in volumes ranging from 1.5cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.
The provided text describes a 510(k) premarket notification for a medical device called SCS 17-01, a resorbable calcium salt bone void filler. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria or conducting a clinical effectiveness study against a defined set of acceptance criteria in humans.
Therefore, many of the requested details, such as specific acceptance criteria for device performance in a clinical setting, human-in-the-loop studies (MRMC), or a comprehensive standalone algorithm performance, are not applicable to this type of submission. The study described is primarily pre-clinical (animal studies) and lab-based testing to show equivalence in properties and performance to existing devices.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to this type of regulatory submission:
Acceptance Criteria and Study for SCS 17-01 (K173008)
This submission is a 510(k) Premarket Notification for a Class II medical device (SCS 17-01, Product Code MQV). The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet new, standalone acceptance criteria for clinical performance that would typically be seen for novel devices or those undergoing PMA. The "acceptance criteria" here are implicitly tied to demonstrating equivalence through comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission based on pre-clinical data and comparison to predicate devices, the "acceptance criteria" are not framed as specific clinical outcome thresholds, but rather as demonstrating similar characteristics and performance in in-vitro and in-vivo (animal) models.
| Category | Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Chemical Composition | Identification of crystalline/non-crystalline components, elemental analysis (including heavy metals), and calcium dissolution profile similar to predicate. | SCS 17-01: Dry powder: alpha phase tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], monocalcium phosphate [Ca(H2PQ4)2]. Liquid: sodium phosphate dibasic [Na2HPO4], citric acid [CoH30], hyaluronic acid (HA), water for injection. |
| Chemical characterization (PXRD, FTIR, ICP-MS) performed. Calcium dissolution performed for subject and primary predicate (HydroSet). Methods: ASTM F1185, ASTM F1926/F1926M. (Performance stated as "demonstrated substantial equivalence" but no specific data values provided in this summary) | ||
| Physical Characteristics | Device mass, volume, density, surface area, porosity, and microstructure similar to predicate. | SCS 17-01: Injectable, settable osteoconductive calcium phosphate material. Physical characterization performed: device mass, volume, density (gas displacement pycnometry), surface area (gas adsorption), porosity (mercury intrusion porosimetry), surface microstructure (SEM). (Performance stated as "demonstrated substantial equivalence" but no specific data values provided in this summary) |
| Biocompatibility | Meet AAMI/ANSI/ISO 10993 series standards for biological evaluation, non-pyrogenic, and low bacterial endotoxin. | Biocompatibility testing performed per AAMI/ANSI/ISO 10993-1, 10993-5, 10993-10, 10993-11, 10993-12. Pyrogenicity & Bacterial endotoxin testing per USP 39-NF 34 & . (Performance stated as compliant but no specific results detailed) |
| Sterilization & Shelf Life | Sterilization validation and shelf life stability demonstrated. | Sterilization validation (AAMI/ANSI/ISO 11137-1, 11137-2) and shelf life testing (ASTM F1140/F1140M, ASTM F2096) performed. (Performance stated as validated but no specific results detailed) |
| In Vivo Performance | Radiographic, histologic, histomorphometric, and mechanical properties demonstrated as equivalent to the primary predicate device in an animal model. | Animal Study (Rabbit Distal Femoral Condyle Critical-Sized Defect Model): Evaluated both SCS 17-01 and primary predicate (HydroSet). Time points: Baseline, 6 weeks, 12 weeks. Controls: Empty defects (negative), Autograft (positive). Endpoints: Radiography, micro-CT, decalcified histologic evaluation, histomorphometric analysis, mechanical testing. Histology graded per AAMI/ANSVISO 10993-6 (Annex E). Result: "The results of the study demonstrated that the performance of the subject device was equivalent to that of the primary predicate device." No specific quantitative data from the study is provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Animal Study): The text mentions a "rabbit distal femoral condyle critical-sized defect model" and that "The baseline (time 0) animals provided information on the initial amount of material implanted to fill the defects. Emptv (unfilled) defects (negative control) and defects filled with autograft (positive control) were evaluated at 6 weeks and 12 weeks."
- Sample Size: The exact number of animals or defects per group (subject device, primary predicate, negative control, positive control, time points) is not specified in the provided text.
- Data Provenance: This was an in vivo animal study. The country of origin is not specified. It is a prospective experimental study in an animal model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable / Not Specified: For the animal study, the "ground truth" would be established by the measured outcomes (radiographic appearance, micro-CT, histology, histomorphometry, mechanical testing). While pathologists or radiologists would interpret the animal data, the number and qualifications of experts involved in analyzing the animal study endpoints are not specified in the provided text. This is not a human clinical study requiring human interpretation of medical images.
4. Adjudication Method for the Test Set
- Not Applicable / Not Specified: As this is primarily an animal study and laboratory testing, there is no mention of a human-based adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as would be common in human diagnostic imaging studies. The data points (e.g., measurements from histology, mechanical tests) would be objective.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: The provided text explicitly states: "No clinical data are included in this submission." An MRMC study involves human readers interpreting clinical cases, which was not performed or submitted for this device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- No: This device is a bone void filler material, not an AI algorithm or software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
- For the animal study, the ground truth was established through a combination of:
- Histology / Histomorphometry: Direct microscopic examination of tissue and quantitative analysis of bone formation/resorption within the defect.
- Radiography and Micro-Computed Tomography (micro-CT): Imaging modalities to visualize the implanted material and surrounding bone.
- Mechanical Testing: Objective measurement of the strength or mechanical properties of the treated bone.
- Expert Review/Pathology: While not explicitly detailed, trained personnel/experts would be involved in interpreting the histologic slides and radiographic images.
- This is an in vivo biological response and physical measurement ground truth in an animal model, not expert consensus on human images, pathology from human biopsies, or human clinical outcomes data.
8. The Sample Size for the Training Set
- Not Applicable: This device is a physical product (bone void filler), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As above, there is no training set for an AI/ML algorithm for this physical device.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.